Clinical Research Updates - Good Clinical Research Practice
Euromed Communications Ltd, June 2012, Pages: 36
Clinical Research Updates bring together guidance on everything to do with clinical trials, from pharmacokinetics and study design, to recruitment, monitoring, protection of subjects, statistics, budgeting ... all the compliance areas you need to conduct clinical trials that will conform to the regulations.
Written by some of the finest experts working in the clinical trials field, Clinical Research Updates translate regulations and best practices into real-world guidance. Both new and experienced trial managers will find the information they need to set up and run every phase of a clinical research program - from drug discovery through post marketing surveillance - in the US or abroad.
Focusing on the US, Europe and Asia, Clinical Research Updates have been updated in 2012 to make it the most current and comprehensive resource available
Introduction
History
What is Good Clinical Practice?
Glossary
The Principles of ICH GCP
Institutional Review Boards/Independent Ethics Committees (IRB/IECS)
Investigator Responsibilities
Sponsor Responsibilities
Clinical Trial Protocol and Protocol Amendments
Investigator's Brochure
Essential Documents for the Conduct of a Clinical Trial
Implications of GCP
National Frameworks for GCP
Conclusions
Further Reading
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